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Phase 1, single-dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of etelcalcetide in pediatric patients with secondary hyperparathyroidism receiving hemodialysis
- Source :
- Pediatric Nephrology. 36:133-142
- Publication Year :
- 2020
- Publisher :
- Springer Science and Business Media LLC, 2020.
-
Abstract
- Data on the safety, efficacy of etelcalcetide in children with secondary hyperparathyroidism (sHPT) are limited.This phase 1 study (NCT02833857) evaluated the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) of single-dose etelcalcetide (0.035 mg/kg intravenously) in pediatric hemodialysis patients (two cohorts; 1: 12-18 years; 2: 2-12 years). Treatment-emergent adverse events (AEs), PK/PD were assessed post-dose on D1 at 10 min and 4 h, on multiple days until D10, and at end of study (D30).Etelcalcetide administered to 11 patients (mean [SD] age 10.3 [4.3] years; cohort 1, n = 6; cohort 2, n = 5) was well tolerated. AEs were consistent with established safety profiles in adults. Two patients (1 per cohort) reported treatment-related AEs (cohort 1: hypocalcemia; cohort 2: headache, paresthesia, vomiting). No serious AEs or deaths were reported. Mean serum corrected calcium (cCa) for all patients was maintained2.25 mmol/L. After etelcalcetide dosing, PK exposures declined, with mean CSingle-dose etelcalcetide (0.035 mg/kg) was well tolerated with expected PK and safety profiles. Overall pattern of changes in serum iPTH and serum calcium was similar between cohorts and consistent with expected responses to etelcalcetide.
- Subjects :
- medicine.medical_specialty
Adolescent
medicine.medical_treatment
030232 urology & nephrology
Cmax
030204 cardiovascular system & hematology
Gastroenterology
03 medical and health sciences
0302 clinical medicine
Pharmacokinetics
Renal Dialysis
Internal medicine
medicine
Humans
Renal Insufficiency, Chronic
Child
Etelcalcetide
business.industry
medicine.disease
Tolerability
Parathyroid Hormone
Nephrology
Child, Preschool
Pharmacodynamics
Pediatrics, Perinatology and Child Health
Cohort
Calcium
Hyperparathyroidism, Secondary
Secondary hyperparathyroidism
Hemodialysis
Peptides
business
Subjects
Details
- ISSN :
- 1432198X and 0931041X
- Volume :
- 36
- Database :
- OpenAIRE
- Journal :
- Pediatric Nephrology
- Accession number :
- edsair.doi.dedup.....b501a14bec6fc3585552ed3e27945314